中华皮肤科杂志 ›› 2014, Vol. 47 ›› Issue (7): 503-505.

• 研究报道 • 上一篇    下一篇

20%氨基酮戊酸光动力治疗外阴尖锐湿疣量效关系临床研究

黄丹1,鞠梅2,钱伊弘3,周平玉3,唐增奇4,杨夕芳5,张小华1,郭庆6,陈崑7,顾恒8   

  1. 1. 中国医学科学院皮肤病研究所理疗科
    2. 南京 中国医学科学院北京协和医学院皮肤病医院
    3. 上海市皮肤病性病医院性病研究室
    4. 广州市中山大学附属第二医院皮肤科
    5. 南京医科院皮研所
    6. 广州市中山大学第二医院皮肤科
    7. 南京 中国医学科学院北京协和医学院皮肤病研究所
    8. 中国医学科学院北京协和医学院皮肤病研究所
  • 收稿日期:2013-09-24 修回日期:2013-10-15 发布日期:2014-07-01
  • 通讯作者: 陈崑 E-mail:kunchen181@aliyun.com

Topical 20% 5-aminolevulinic acid-based photodynamic therapy for the treatment of condyloma acuminatum of the vulva: a multicenter, randomized clinical evaluation of dose-response relationship

  • Received:2013-09-24 Revised:2013-10-15 Published:2014-07-01

摘要: 目的 比较在固定敷药面积的前提下外用不同剂量20%盐酸氨基酮戊酸溶液(ALA)进行光动力疗法(ALA-PDT)治疗外阴尖锐湿疣的安全性与疗效。 方法 随机、开放、两个剂量组平行对照的多中心临床研究,就诊的尖锐湿疣患者按随机号分配进入A组或B组,A组外用0.5 ml 20% ALA,B组外用0.25 ml 20% ALA,敷药范围的直径均为2 cm,外用聚乙烯薄膜封包,胶布固定。3 h后使用红光照射,能量密度80 ~ 120 J/cm2。两组均7 ~ 10 d重复治疗1次,共治疗3次。每次治疗后进行疗效评价和不良反应观察,末次治疗后第1、4、8、12、24周进行随访,观察复发率。 结果 3个中心共入组尖锐湿疣患者88例,其中81例完成全部治疗(A组45例,B组36例),A组总疣体数为55个,B组为49个。治疗3次后A组疣体清除率为98.18%,B组为85.71%,两组差异有统计学意义(χ2 = 5.67,P < 0.05);痊愈率分别为97.77%和80.55%,差异有统计学意义(χ2 = 6.66,P < 0.05)。治疗结束后第12周,A组复发率为9.09%(4/44),B组为35.71%(10/28),差异有统计学意义(χ2 = 7.74,P < 0.01)。不良反应A、B两组分别为33.33%、30.55%,差异无统计学意义(χ2 = 0.07,P > 0.05),不良反应有局部红肿、疼痛、糜烂,均在1 ~ 5 d内自行缓解。 结论 固定敷药面积时,外用0.5 ml 20% ALA-PDT疗法治疗外阴尖锐湿疣疗效优于0.25 ml,复发率显著降低,同时不良反应未见明显增加。

关键词: 尖锐湿疣, 氨基酮戊酸, 光化学疗法, 剂量效应关系,药物

Abstract: Huang Dan*, Ju Mei, Qian Yihong, Zhou Pingyu, Tang Zengqi, Yang Xifang, Zhang Xiaohua, Guo Qing, Chen Kun, Gu Heng. *Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical Collage, Nanjing 210042, China Corresponding authors: Chen Kun, Email: kunchen181@aliyun.com; Ju Mei, jumeiweng@163.com 【Abstract】 Objective To compare the safety and efficacy of two doses of topical 20% 5-aminolevulinic acid (ALA) in photodynamic therapy(PDT) for condyloma acuminatum of the vulva on the premise that the area to be topically treated is fixed. Methods An open, randomized, parallel-group controlled clinical trial was performed in three institutions in eastern China. Patients with condyloma acuminatum of the vulva were randomly divided into two groups according to a random number table: group A and group B applying 0.5 ml and 0.25 ml of 20% ALA solution, respectively, to an area measuring 2 cm in diameter followed by polyethylene film coating and adhesive tape fixation. All the patients were treated for three times with an interval of 7 - 10 days. Efficacy was evaluated and adverse reactions were recorded after each treatment, and follow-up was scheduled on week 1, 4, 8, 12 and 24 after the last treatment for the observation of recurrence rate. Results A total of 88 patients with genital condyloma acuminatum were enrolled in this trail, and 81 patients completed all the treatment, including 45 patients with 55 warts in group A and 36 patients with 49 warts in group B. After 3 times of treatment, significant differences were observed in wart clearance rate (98.18% vs. 85.71%, χ2 = 5.67, P < 0.05) and cure rate (97.77% vs. 80.55%, χ2 = 6.66, P < 0.05). The overall recurrence rate during 12 weeks after the last treatment was significantly lower in group A than in group B(9.09% (4/44) vs. 35.71% (10.28) , χ2 = 7.74, P < 0.01). Adverse reactions mainly included local swelling, pain and erosion, and all spontaneously subsided within 1 to 5 days. Further more, no significant difference was observed in the occurrence rate of adverse reactions between group A and B (33.33% vs. 30.55%, P > 0.05). Conclusions Given that the area to be topically treated is fixed, 0.5 ml of 20% ALA is superior to 0.25 ml of 20% ALA in the photodynamic treatment of condyloma acuminatum of the vulva with favorable efficacy, reduced recurrence and similar adverse reactions.

Key words: Condylomata acuminata, Aminolevulinic acid, Photochemotherapy, Dose-response relationship, drug

引用本文

黄丹 鞠梅 钱伊弘 周平玉 唐增奇 杨夕芳 张小华 郭庆 陈崑 顾恒. 20%氨基酮戊酸光动力治疗外阴尖锐湿疣量效关系临床研究[J]. 中华皮肤科杂志, 2014,47(7):503-505. doi: